Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a multicenter, open-label, Phase 2 study to assess the efficacy and safety of tazemetostat in participants with relapsed or refractory B-cell non-Hodgkin's lymphoma (NHL) with EZH2 gene mutation.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FL with EZH2 gene mutation | Experimental | Participants with follicular lymphoma (FL) with the EZH2 gene mutation will receive oral tazemetostat at a starting dose of 800 milligrams (mg) twice daily (1600 mg total daily dose) by continuous regimen, no less than 8 hours between doses. |
|
| DLBCL with EZH2 gene mutation | Experimental | Participants with diffuse large B-cell lymphoma (DLBCL) with the EZH2 gene mutation will receive oral tazemetostat at a starting dose of 800 mg twice daily (1600 mg total daily dose) by continuous regimen, no less than 8 hours between doses. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tazemetostat | Drug | Tazemetostat will be provided as a 200 mg oral tablet. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) Based on Independent Reviewer Assessment | ORR was defined as percentage of participants with confirmed best overall response (BOR) of complete response (CR) or partial response (PR) using independent reviewer assessment based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. BOR of CR and PR was confirmed by a subsequent CR assessment and CR or PR assessment. CR: disappearance of all measurable, non-measurable lesions and no unequivocal new lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to less than (<) 10 millimeter (mm). PR: at least a 30 percent (%) decrease in sum of diameters (SOD) of target lesions, taking as reference the baseline SOD and there are no unequivocal new lesions, and no progression of non-target disease. The 2-sided 95% confidence interval (CI) was calculated by Clopper-Pearson method. | From date of first dose of study drug administration to date of PD or death, whichever occurred first (up to 3 years 4 months) |
| ORR Based on Investigator Assessment | ORR was defined as percentage of participants with confirmed BOR of CR or PR using investigator assessment based on RECIST 1.1. BOR of CR and PR was confirmed by a subsequent CR assessment and CR or PR assessment. CR: disappearance of all measurable, non-measurable lesions and no unequivocal new lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis <10 mm. PR: at least a 30% decrease in SOD of target lesions, taking as reference the baseline SOD and there are no unequivocal new lesions, and no progression of non-target disease. The 2-sided 95% CI was calculated by Clopper-Pearson method. | From date of first dose of study drug administration to date of PD or death, whichever occurred first (up to 3 years 4 months) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-free Survival (PFS) Based on Independent Reviewer Assessment | PFS was assessed by independent reviewer assessment based on RECIST 1.1. PFS was defined as the time from the date of the first dose of study drug to the date of the first documentation of PD or death, whichever occurred first. PD for target lesion, a minimum 20% increase and a minimum 5 mm absolute increase in SOD compared to nadir, or PD for non-target lesion(s) or unequivocal new lesion(s). Nadir: Lowest measure SOD of target lesion at any time point from baseline onward. The 95% CI was calculated using Kaplan-Meier estimate. |
Not provided
Inclusion Criteria:
Participants with histological diagnosis of B-cell non-Hodgkin's lymphoma (NHL) as follows:
Participants who have confirmed EZH2 gene mutation of tumor in central laboratory
Participants who have measurable disease
Participants who had previous therapy with systemic chemotherapy and/or antibody therapy and for which no standard therapy exists
Participants who had progressive disease or did not have response (complete response or partial response) in previous systemic therapy, or relapsed or progressed after previous systemic therapy
Participants with Eastern Cooperative Oncology Group performance status of 0 to 1
Participants with life expectancy of ≥3 months from starting study drug administration
Participants with adequate renal, liver, and bone marrow function
Male and female participants ≥20 years of age at the time of informed consent
Participants who has provided written consent to participate in the study
Exclusion Criteria:
Participants with prior exposure to EZH2 inhibitor
Participants with a history or a presence of central nerves invasion
Participants with malignant pleural effusion, cardiac effusion, or ascites retention
Participants with allogeneic stem cell transplantation
Participants with medical need for the continued use of potent inhibitors of Cytochrome P450 3A (CYP3A)or potent inducer of CYP3A (including St. John's wort)
Participants with significant cardiovascular impairment
· Participants with prolongation of corrected QT interval using Fridericia's formula to > 480 milliseconds (msec)
Participants with venous thrombosis or pulmonary embolism within the last 3 months before starting study drug
Participants with complications of hepatic cirrhosis, interstitial pneumonia or pulmonary fibrosis
Participants with active infection requiring systemic therapy
Women of childbearing potential or man of impregnate potential who don't agree that both the participant and his/her partner will use a medically effective method for contraception for periods from before informed consent to during the clinical study and 30 days later (for males 90 days later) from last administration of study drug
Woman who are pregnant or breastfeeding
Participants who were deemed as inappropriate to participate in the study by the investigator or sub-investigator
Have any prior history of T-cell lymphoblastic lymphoma/T-cell acute lymphoblastic leukemia or myeloid malignancies, including myelodysplastic syndrome
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| 1004 Eisai Trial Site | Nagoya | Aichi-ken | Japan | |||
| 1029 Eisai Trial Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39179948 | Derived | Izutsu K, Ando K, Nishikori M, Shibayama H, Goto H, Kuroda J, Kato K, Imaizumi Y, Nosaka K, Sakai R, Abe M, Hojo S, Nakanishi T, Rai S. Tazemetostat for relapsed/refractory B-cell non-Hodgkin lymphoma with EZH2 mutation in Japan: 3-year follow-up for a phase II study. Int J Hematol. 2024 Nov;120(5):621-630. doi: 10.1007/s12185-024-03834-9. Epub 2024 Aug 23. |
Not provided
Not provided
A total of 100 participants were screened, of which 80 were screen failures and only 20 participants were eligible to enter the study and received the study treatment.
Participants took part in the study at 28 investigative sites in Japan from 09 April 2018 to 17 December 2021.
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Participants With Follicular Lymphoma | Participants with follicular lymphoma (FL) with the enhancer of zeste homolog 2 (EZH2) gene mutation received oral tazemetostat tablet at a starting dose of 800 milligrams (mg) twice daily (1600 mg total daily dose) in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) by continuous regimen, no less than 8 hours between doses until disease progression (PD), development of unacceptable toxicity, participant's requests to discontinue, withdrawal of consent, or study termination by the sponsor. |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jan 29, 2021 | Nov 18, 2022 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| From date of first dose of study drug administration to date of PD or death, whichever occurred first (up to 3 years 4 months) |
| PFS Based on Investigator Assessment | PFS was assessed by investigator assessment based on RECIST 1.1. PFS was defined as the time from the date of the first dose of study drug to the date of the first documentation of PD or death, whichever occurred first. PD for target lesion, a minimum 20% increase and a minimum 5 mm absolute increase in SOD compared to nadir, or PD for non-target lesion(s) or unequivocal new lesion(s). Nadir: Lowest measure SOD of target lesion at any time point from baseline onward. The 95% CI was calculated using Kaplan-Meier estimate. | From date of first dose of study drug administration to date of PD or death, whichever occurred first (up to 3 years 4 months) |
| Duration of Response (DOR) Based on Independent Reviewer Assessment | DOR: time from date of confirmation of the first response and the date of confirmation of the PD using independent reviewer assessment as per RECIST 1.1. BOR of CR and PR was confirmed by subsequent CR assessment and CR or PR assessment, respectively at least 4 weeks later. CR: disappearance of all measurable, non-measurable lesions and no unequivocal new lesions. Any pathological lymph nodes had to be reduced in short axis to <10 mm. PR: at least 30% decrease in SOD of target lesions, taking as reference the baseline SOD, there are no unequivocal new lesions, and no progression of non-target disease. PD for target lesion, a minimum 20% increase and a minimum 5mm absolute increase in SOD compared to nadir, or PD for non-target lesions or unequivocal new lesions. Nadir: Lowest measure SOD of target lesions at any time point from baseline onward. The 95% CI was calculated using Kaplan-Meier estimate. | From the date of first confirmed objective response (OR) to PD or death due to confirmed PR or CR (up to 3 years 4 months) |
| DOR Based on Investigator Assessment | DOR: time from date of confirmation of the first response and the date of confirmation of the PD using independent reviewer assessment as per RECIST 1.1. BOR of CR and PR was confirmed by subsequent CR assessment and CR or PR assessment, respectively at least 4 weeks later. CR: disappearance of all measurable, non-measurable lesions and no unequivocal new lesions. Any pathological lymph nodes had to be reduced in short axis to <10 mm. PR: at least 30% decrease in SOD of target lesions, taking as reference the baseline SOD, there are no unequivocal new lesions, and no progression of non-target disease. PD for target lesion, a minimum 20% increase and a minimum 5mm absolute increase in SOD compared to nadir, or PD for non-target lesions or unequivocal new lesions. Nadir: Lowest measure SOD of target lesions at any time point from baseline onward. The 95% CI was calculated using Kaplan-Meier estimate. | From the date of first confirmed OR to PD or death due to any cause for those participants with a confirmed PR or CR (up to 3 years 4 months) |
| Time to Response (TTR) Based on Independent Reviewer Assessment | TTR was defined as the time from the first dose of the study drug to date of first observation of CR or PR using independent reviewer assessment based on RECIST 1.1. CR: disappearance of all measurable, non-measurable lesions and no unequivocal new lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to <10 mm. PR: at least a 30% decrease in SOD of target lesions, taking as reference the baseline SOD and there are no unequivocal new lesions, and no progression of non-target disease. | From the date of first dose until date of first observation of CR or PR (up to 3 years 4 months) |
| TTR Based on Investigator Assessment | TTR was defined as the time from the first dose of the study drug to date of first observation of CR or PR using investigator assessment based on RECIST 1.1. CR: disappearance of all measurable, non-measurable lesions and no unequivocal new lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to <10 mm. PR: at least a 30% decrease in SOD of target lesions, taking as reference the baseline SOD and there are no unequivocal new lesions, and no progression of non-target disease. | From the date of first dose until date of first observation of CR or PR (up to 3 years 4 months) |
| Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAE is defined as an AE that emerged during time from the first dose of study drug to 30 days after the participant's last dose. An AE was any untoward medical occurrence in participant administered with an investigational product. An SAE was any untoward medical occurrence that at any dose: resulted in death; life threatening; requires participant hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). | From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months) |
| Nagoya |
| Aichi-ken |
| Japan |
| 1020 Eisai Trial Site | Ōta | Gunma | Japan |
| 1007 Eisai Trial Site | Sapporo | Hokkaido | Japan |
| 1019 Eisai Trial Site | Kobe | Hyōgo | Japan |
| 1005 Eisai Trial Site | Tsukuba | Ibaraki | Japan |
| 1002 Eisai Trial Site | Isehara | Kanagawa | Japan |
| 1028 Eisai Trial Site | Yokohama | Kanagawa | Japan |
| 1021 Eisai Trial Site | Sendai | Miyagi | Japan |
| 1013 Eisai Trial Site | Sayama | Osaka | Japan |
| 1006 Eisai Trial Site | Suita | Osaka | Japan |
| 1027 Eisai Trial Site | Suntou-gun | Shizuoka | Japan |
| 1026 Eisai Trial Site | Bunkyo-ku | Tokyo | Japan |
| 1001 Eisai Trial Site | Chuo-ku | Tokyo | Japan |
| 1025 Eisai Trial Site | Koto-ku | Tokyo | Japan |
| 1017 Eisai Trial Site | Minato-ku | Tokyo | Japan |
| 1022 Eisai Trial Site | Aomori | Japan |
| 1010 Eisai Trial Site | Chiba | Japan |
| 1012 Eisai Trial Site | Fukuoka | Japan |
| 1016 Eisai Trial Site | Fukuoka | Japan |
| 1011 Eisai Trial Site | Hiroshima | Japan |
| 1024 Eisai Trial Site | Kumamoto | Japan |
| 1003 Eisai Trial Site | Kyoto | Japan |
| 1008 Eisai Trial Site | Kyoto | Japan |
| 1023 Eisai Trial Site | Nagasaki | Japan |
| 1009 Eisai Trial Site | Okayama | Japan |
| 1015 Eisai Trial Site | Osaka | Japan |
| 1018 Eisai Trial Site | Yamagata | Japan |
| FG001 | Participants With Diffuse Large B-cell Lymphoma | Participants with diffuse large B-cell lymphoma (DLBCL) with the EZH2 gene mutation received oral tazemetostat at a starting dose of 800 mg twice daily (1600 mg total daily dose) in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) by continuous regimen, no less than 8 hours between doses until PD, development of unacceptable toxicity, participant's requests to discontinue, withdrawal of consent, or study termination by the sponsor. |
| COMPLETED |
|
| NOT COMPLETED |
|
|
The safety analysis set included participants who received at least 1 administration of the study drug.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Participants With Follicular Lymphoma | Participants with FL with the EZH2 gene mutation received oral tazemetostat tablet at a starting dose of 800 mg twice daily (1600 mg total daily dose) in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) by continuous regimen, no less than 8 hours between doses until PD, development of unacceptable toxicity, participant's requests to discontinue, withdrawal of consent, or study termination by the sponsor. |
| BG001 | Participants With Diffuse Large B-cell Lymphoma | Participants with DLBCL with the EZH2 gene mutation received oral tazemetostat at a starting dose of 800 mg twice daily (1600 mg total daily dose) in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) by continuous regimen, no less than 8 hours between doses until PD, development of unacceptable toxicity, participant's requests to discontinue, withdrawal of consent, or study termination by the sponsor. |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Objective Response Rate (ORR) Based on Independent Reviewer Assessment | ORR was defined as percentage of participants with confirmed best overall response (BOR) of complete response (CR) or partial response (PR) using independent reviewer assessment based on Response Evaluation Criteria in Solid Tumors (RECIST) 1.1. BOR of CR and PR was confirmed by a subsequent CR assessment and CR or PR assessment. CR: disappearance of all measurable, non-measurable lesions and no unequivocal new lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to less than (<) 10 millimeter (mm). PR: at least a 30 percent (%) decrease in sum of diameters (SOD) of target lesions, taking as reference the baseline SOD and there are no unequivocal new lesions, and no progression of non-target disease. The 2-sided 95% confidence interval (CI) was calculated by Clopper-Pearson method. | The efficacy analysis set included efficacy evaluable participants who received at least 1 administration of the study drug and who has appropriate tumor assessment data of Screening 2 (Screening 2 was conducted in this study to confirm the other eligibility for study treatment) and post-baseline. | Posted | Number | 95% Confidence Interval | percentage of participants | From date of first dose of study drug administration to date of PD or death, whichever occurred first (up to 3 years 4 months) |
|
|
| ||||||||||||||||||||||||||||
| Primary | ORR Based on Investigator Assessment | ORR was defined as percentage of participants with confirmed BOR of CR or PR using investigator assessment based on RECIST 1.1. BOR of CR and PR was confirmed by a subsequent CR assessment and CR or PR assessment. CR: disappearance of all measurable, non-measurable lesions and no unequivocal new lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis <10 mm. PR: at least a 30% decrease in SOD of target lesions, taking as reference the baseline SOD and there are no unequivocal new lesions, and no progression of non-target disease. The 2-sided 95% CI was calculated by Clopper-Pearson method. | The efficacy analysis set included efficacy evaluable participants who received at least 1 administration of the study drug and who has appropriate tumor assessment data of Screening 2 (Screening 2 was conducted in this study to confirm the other eligibility for study treatment) and post-baseline. | Posted | Number | 95% Confidence Interval | percentage of participants | From date of first dose of study drug administration to date of PD or death, whichever occurred first (up to 3 years 4 months) |
| ||||||||||||||||||||||||||||||
| Secondary | Progression-free Survival (PFS) Based on Independent Reviewer Assessment | PFS was assessed by independent reviewer assessment based on RECIST 1.1. PFS was defined as the time from the date of the first dose of study drug to the date of the first documentation of PD or death, whichever occurred first. PD for target lesion, a minimum 20% increase and a minimum 5 mm absolute increase in SOD compared to nadir, or PD for non-target lesion(s) or unequivocal new lesion(s). Nadir: Lowest measure SOD of target lesion at any time point from baseline onward. The 95% CI was calculated using Kaplan-Meier estimate. | The efficacy analysis set included efficacy evaluable participants who received at least 1 administration of the study drug and who has appropriate tumor assessment data of Screening 2 (Screening 2 was conducted in this study to confirm the other eligibility for study treatment) and post-baseline. | Posted | Median | 95% Confidence Interval | months | From date of first dose of study drug administration to date of PD or death, whichever occurred first (up to 3 years 4 months) |
| ||||||||||||||||||||||||||||||
| Secondary | PFS Based on Investigator Assessment | PFS was assessed by investigator assessment based on RECIST 1.1. PFS was defined as the time from the date of the first dose of study drug to the date of the first documentation of PD or death, whichever occurred first. PD for target lesion, a minimum 20% increase and a minimum 5 mm absolute increase in SOD compared to nadir, or PD for non-target lesion(s) or unequivocal new lesion(s). Nadir: Lowest measure SOD of target lesion at any time point from baseline onward. The 95% CI was calculated using Kaplan-Meier estimate. | The efficacy analysis set included efficacy evaluable participants who received at least 1 administration of the study drug and who has appropriate tumor assessment data of Screening 2 (Screening 2 was conducted in this study to confirm the other eligibility for study treatment) and post-baseline. | Posted | Median | 95% Confidence Interval | months | From date of first dose of study drug administration to date of PD or death, whichever occurred first (up to 3 years 4 months) |
| ||||||||||||||||||||||||||||||
| Secondary | Duration of Response (DOR) Based on Independent Reviewer Assessment | DOR: time from date of confirmation of the first response and the date of confirmation of the PD using independent reviewer assessment as per RECIST 1.1. BOR of CR and PR was confirmed by subsequent CR assessment and CR or PR assessment, respectively at least 4 weeks later. CR: disappearance of all measurable, non-measurable lesions and no unequivocal new lesions. Any pathological lymph nodes had to be reduced in short axis to <10 mm. PR: at least 30% decrease in SOD of target lesions, taking as reference the baseline SOD, there are no unequivocal new lesions, and no progression of non-target disease. PD for target lesion, a minimum 20% increase and a minimum 5mm absolute increase in SOD compared to nadir, or PD for non-target lesions or unequivocal new lesions. Nadir: Lowest measure SOD of target lesions at any time point from baseline onward. The 95% CI was calculated using Kaplan-Meier estimate. | The efficacy analysis set included efficacy evaluable participants who received at least 1 administration of the study drug and who has appropriate tumor assessment data of Screening 2 (Screening 2 was conducted in this study to confirm the other eligibility for study treatment) and post-baseline. Here, Overall number of participants analyzed signifies participants who had OR (CR or PR) as per Independent Reviewer Assessment. | Posted | Median | 95% Confidence Interval | months | From the date of first confirmed objective response (OR) to PD or death due to confirmed PR or CR (up to 3 years 4 months) |
| ||||||||||||||||||||||||||||||
| Secondary | DOR Based on Investigator Assessment | DOR: time from date of confirmation of the first response and the date of confirmation of the PD using independent reviewer assessment as per RECIST 1.1. BOR of CR and PR was confirmed by subsequent CR assessment and CR or PR assessment, respectively at least 4 weeks later. CR: disappearance of all measurable, non-measurable lesions and no unequivocal new lesions. Any pathological lymph nodes had to be reduced in short axis to <10 mm. PR: at least 30% decrease in SOD of target lesions, taking as reference the baseline SOD, there are no unequivocal new lesions, and no progression of non-target disease. PD for target lesion, a minimum 20% increase and a minimum 5mm absolute increase in SOD compared to nadir, or PD for non-target lesions or unequivocal new lesions. Nadir: Lowest measure SOD of target lesions at any time point from baseline onward. The 95% CI was calculated using Kaplan-Meier estimate. | The efficacy analysis set included efficacy evaluable participants who received at least 1 administration of the study drug and who has appropriate tumor assessment data of Screening 2 (Screening 2 was conducted in this study to confirm the other eligibility for study treatment) and post-baseline. Here, Overall number of participants analyzed signifies participants who had OR (CR or PR) as per Investigator Assessment. | Posted | Median | 95% Confidence Interval | months | From the date of first confirmed OR to PD or death due to any cause for those participants with a confirmed PR or CR (up to 3 years 4 months) |
| ||||||||||||||||||||||||||||||
| Secondary | Time to Response (TTR) Based on Independent Reviewer Assessment | TTR was defined as the time from the first dose of the study drug to date of first observation of CR or PR using independent reviewer assessment based on RECIST 1.1. CR: disappearance of all measurable, non-measurable lesions and no unequivocal new lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to <10 mm. PR: at least a 30% decrease in SOD of target lesions, taking as reference the baseline SOD and there are no unequivocal new lesions, and no progression of non-target disease. | The efficacy analysis set included efficacy evaluable participants who received at least 1 administration of the study drug and who has appropriate tumor assessment data of Screening 2 (Screening 2 was conducted in this study to confirm the other eligibility for study treatment) and post-baseline. Here, Overall number of participants analyzed signifies participants who had OR (CR or PR) as per Independent Reviewer Assessment. | Posted | Median | Full Range | months | From the date of first dose until date of first observation of CR or PR (up to 3 years 4 months) |
| ||||||||||||||||||||||||||||||
| Secondary | TTR Based on Investigator Assessment | TTR was defined as the time from the first dose of the study drug to date of first observation of CR or PR using investigator assessment based on RECIST 1.1. CR: disappearance of all measurable, non-measurable lesions and no unequivocal new lesions. Any pathological lymph nodes (target or non-target) had to be reduced in short axis to <10 mm. PR: at least a 30% decrease in SOD of target lesions, taking as reference the baseline SOD and there are no unequivocal new lesions, and no progression of non-target disease. | The efficacy analysis set included efficacy evaluable participants who received at least 1 administration of the study drug and who has appropriate tumor assessment data of Screening 2 (Screening 2 was conducted in this study to confirm the other eligibility for study treatment) and post-baseline. Here, Overall number of participants analyzed signifies participants who had OR (CR or PR) as per Investigator Assessment. | Posted | Median | Full Range | months | From the date of first dose until date of first observation of CR or PR (up to 3 years 4 months) |
| ||||||||||||||||||||||||||||||
| Secondary | Number of Participants With Any Treatment-emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) | TEAE is defined as an AE that emerged during time from the first dose of study drug to 30 days after the participant's last dose. An AE was any untoward medical occurrence in participant administered with an investigational product. An SAE was any untoward medical occurrence that at any dose: resulted in death; life threatening; requires participant hospitalization or prolongation of existing hospitalization; resulted in persistent or significant disability/incapacity; was a congenital anomaly/birth defect (in the child of a participant who was exposed to the study drug). | The safety analysis set included participants who received at least 1 administration of the study drug. | Posted | Count of Participants | Participants | From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months) |
|
From the first dose of study drug to 30 days after the last dose (up to 3 years 5 months)
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Participants With Follicular Lymphoma | Participants with FL with the EZH2 gene mutation received oral tazemetostat tablet at a starting dose of 800 mg twice daily (1600 mg total daily dose) in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) by continuous regimen, no less than 8 hours between doses until PD, development of unacceptable toxicity, participant's requests to discontinue, withdrawal of consent, or study termination by the sponsor. | 0 | 17 | 8 | 17 | 17 | 17 |
| EG001 | Participants With Diffuse Large B-cell Lymphoma | Participants with DLBCL with the EZH2 gene mutation received oral tazemetostat at a starting dose of 800 mg twice daily (1600 mg total daily dose) in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) by continuous regimen, no less than 8 hours between doses until PD, development of unacceptable toxicity, participant's requests to discontinue, withdrawal of consent, or study termination by the sponsor. | 0 | 3 | 1 | 3 | 3 | 3 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Mechanical ileus | Gastrointestinal disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Atypical pneumonia | Infections and infestations | MedDRA version 22.0 | Systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA version 22.0 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA version 22.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 22.0 | Systematic Assessment |
| |
| Traumatic intracranial haemorrhage | Injury, poisoning and procedural complications | MedDRA version 22.0 | Systematic Assessment |
| |
| Gastric cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 22.0 | Systematic Assessment |
| |
| Non-small cell lung cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 22.0 | Systematic Assessment |
| |
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 22.0 | Systematic Assessment |
| |
| Pneumonia aspiration | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | Systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Neutropenia | Blood and lymphatic system disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Thrombocytopenia | Blood and lymphatic system disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Anaemia | Blood and lymphatic system disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Hypochromic anaemia | Blood and lymphatic system disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Leukopenia | Blood and lymphatic system disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Pericardial effusion | Cardiac disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Supraventricular tachycardia | Cardiac disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Conjunctival haemorrhage | Eye disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Cataract | Eye disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Visual impairment | Eye disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Constipation | Gastrointestinal disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Stomatitis | Gastrointestinal disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Abdominal pain | Gastrointestinal disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Epigastric discomfort | Gastrointestinal disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Haematochezia | Gastrointestinal disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Large intestine polyp | Gastrointestinal disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Tooth disorder | Gastrointestinal disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Fatigue | General disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Malaise | General disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Non-cardiac chest pain | General disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Oedema peripheral | General disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Hypogammaglobulinaemia | Immune system disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA version 22.0 | Systematic Assessment |
| |
| Upper respiratory tract infection | Infections and infestations | MedDRA version 22.0 | Systematic Assessment |
| |
| Herpes simplex | Infections and infestations | MedDRA version 22.0 | Systematic Assessment |
| |
| Influenza | Infections and infestations | MedDRA version 22.0 | Systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA version 22.0 | Systematic Assessment |
| |
| Urinary tract infection | Infections and infestations | MedDRA version 22.0 | Systematic Assessment |
| |
| Bronchitis | Infections and infestations | MedDRA version 22.0 | Systematic Assessment |
| |
| Gastroenteritis | Infections and infestations | MedDRA version 22.0 | Systematic Assessment |
| |
| Impetigo | Infections and infestations | MedDRA version 22.0 | Systematic Assessment |
| |
| Oral herpes | Infections and infestations | MedDRA version 22.0 | Systematic Assessment |
| |
| Paronychia | Infections and infestations | MedDRA version 22.0 | Systematic Assessment |
| |
| Periodontitis | Infections and infestations | MedDRA version 22.0 | Systematic Assessment |
| |
| Pneumocystis jirovecii pneumonia | Infections and infestations | MedDRA version 22.0 | Systematic Assessment |
| |
| Fall | Injury, poisoning and procedural complications | MedDRA version 22.0 | Systematic Assessment |
| |
| Postoperative delirium | Injury, poisoning and procedural complications | MedDRA version 22.0 | Systematic Assessment |
| |
| Procedural pain | Injury, poisoning and procedural complications | MedDRA version 22.0 | Systematic Assessment |
| |
| Skin laceration | Injury, poisoning and procedural complications | MedDRA version 22.0 | Systematic Assessment |
| |
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA version 22.0 | Systematic Assessment |
| |
| Traumatic fracture | Injury, poisoning and procedural complications | MedDRA version 22.0 | Systematic Assessment |
| |
| Blood creatine phosphokinase increased | Investigations | MedDRA version 22.0 | Systematic Assessment |
| |
| Blood creatinine increased | Investigations | MedDRA version 22.0 | Systematic Assessment |
| |
| Weight decreased | Investigations | MedDRA version 22.0 | Systematic Assessment |
| |
| Amylase increased | Investigations | MedDRA version 22.0 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA version 22.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA version 22.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA version 22.0 | Systematic Assessment |
| |
| Blood pressure decreased | Investigations | MedDRA version 22.0 | Systematic Assessment |
| |
| Blood zinc decreased | Investigations | MedDRA version 22.0 | Systematic Assessment |
| |
| Gamma-glutamyltransferase increased | Investigations | MedDRA version 22.0 | Systematic Assessment |
| |
| Immature granulocyte count increased | Investigations | MedDRA version 22.0 | Systematic Assessment |
| |
| Hypertriglyceridaemia | Metabolism and nutrition disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Hypophosphataemia | Metabolism and nutrition disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Hyperglycaemia | Metabolism and nutrition disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Hyperkalaemia | Metabolism and nutrition disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Hyperuricaemia | Metabolism and nutrition disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Hypoalbuminaemia | Metabolism and nutrition disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Arthralgia | Musculoskeletal and connective tissue disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Musculoskeletal chest pain | Musculoskeletal and connective tissue disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Osteonecrosis of jaw | Musculoskeletal and connective tissue disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Pain in extremity | Musculoskeletal and connective tissue disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Tendon disorder | Musculoskeletal and connective tissue disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Myelodysplastic syndrome | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 22.0 | Systematic Assessment |
| |
| Oesophageal carcinoma | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA version 22.0 | Systematic Assessment |
| |
| Dysgeusia | Nervous system disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Dizziness | Nervous system disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Muscle spasticity | Nervous system disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Peripheral motor neuropathy | Nervous system disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Sciatica | Nervous system disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Syncope | Nervous system disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Visual field defect | Nervous system disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Insomnia | Psychiatric disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Haematuria | Renal and urinary disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Hypertonic bladder | Renal and urinary disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Asthma | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Dysphonia | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Upper respiratory tract inflammation | Respiratory, thoracic and mediastinal disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Alopecia | Skin and subcutaneous tissue disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Eczema | Skin and subcutaneous tissue disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Erythema multiforme | Skin and subcutaneous tissue disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Keloid scar | Skin and subcutaneous tissue disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Nail disorder | Skin and subcutaneous tissue disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Rash maculo-papular | Skin and subcutaneous tissue disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Hypertension | Vascular disorders | MedDRA version 22.0 | Systematic Assessment |
| |
| Phlebitis | Vascular disorders | MedDRA version 22.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Eisai Inquiry Service | Eisai Co., Ltd | None | eisai-chiken_hotline@hhc.eisai.co.jp |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 31, 2022 | Nov 18, 2022 | SAP_001.pdf |
| ID | Term |
|---|---|
| D012008 | Recurrence |
| D016393 | Lymphoma, B-Cell |
| D016403 | Lymphoma, Large B-Cell, Diffuse |
| D008224 | Lymphoma, Follicular |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D008228 | Lymphoma, Non-Hodgkin |
| D008223 | Lymphoma |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008232 | Lymphoproliferative Disorders |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000593333 | tazemetostat |
Not provided
Not provided
Not provided
| Male |
|
| Not Hispanic or Latino |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| OG001 |
| Participants With Diffuse Large B-cell Lymphoma |
Participants with DLBCL with the EZH2 gene mutation received oral tazemetostat at a starting dose of 800 mg twice daily (1600 mg total daily dose) in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) by continuous regimen, no less than 8 hours between doses until PD, development of unacceptable toxicity, participant's requests to discontinue, withdrawal of consent, or study termination by the sponsor. |
|
|
| Participants With Diffuse Large B-cell Lymphoma |
Participants with DLBCL with the EZH2 gene mutation received oral tazemetostat at a starting dose of 800 mg twice daily (1600 mg total daily dose) in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) by continuous regimen, no less than 8 hours between doses until PD, development of unacceptable toxicity, participant's requests to discontinue, withdrawal of consent, or study termination by the sponsor. |
|
|
Participants with DLBCL with the EZH2 gene mutation received oral tazemetostat at a starting dose of 800 mg twice daily (1600 mg total daily dose) in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) by continuous regimen, no less than 8 hours between doses until PD, development of unacceptable toxicity, participant's requests to discontinue, withdrawal of consent, or study termination by the sponsor. |
|
|
| OG001 | Participants With Diffuse Large B-cell Lymphoma | Participants with DLBCL with the EZH2 gene mutation received oral tazemetostat at a starting dose of 800 mg twice daily (1600 mg total daily dose) in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) by continuous regimen, no less than 8 hours between doses until PD, development of unacceptable toxicity, participant's requests to discontinue, withdrawal of consent, or study termination by the sponsor. |
|
|
| OG001 | Participants With Diffuse Large B-cell Lymphoma | Participants with DLBCL with the EZH2 gene mutation received oral tazemetostat at a starting dose of 800 mg twice daily (1600 mg total daily dose) in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) by continuous regimen, no less than 8 hours between doses until PD, development of unacceptable toxicity, participant's requests to discontinue, withdrawal of consent, or study termination by the sponsor. |
|
|
| OG001 |
| Participants With Diffuse Large B-cell Lymphoma |
Participants with DLBCL with the EZH2 gene mutation received oral tazemetostat at a starting dose of 800 mg twice daily (1600 mg total daily dose) in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) by continuous regimen, no less than 8 hours between doses until PD, development of unacceptable toxicity, participant's requests to discontinue, withdrawal of consent, or study termination by the sponsor. |
|
|
| Participants With Diffuse Large B-cell Lymphoma |
Participants with DLBCL with the EZH2 gene mutation received oral tazemetostat at a starting dose of 800 mg twice daily (1600 mg total daily dose) in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) by continuous regimen, no less than 8 hours between doses until PD, development of unacceptable toxicity, participant's requests to discontinue, withdrawal of consent, or study termination by the sponsor. |
|
|
Participants with DLBCL with the EZH2 gene mutation received oral tazemetostat at a starting dose of 800 mg twice daily (1600 mg total daily dose) in Cycle 1 and 2 and subsequent cycles (Cycle length=28 days) by continuous regimen, no less than 8 hours between doses until PD, development of unacceptable toxicity, participant's requests to discontinue, withdrawal of consent, or study termination by the sponsor.
|
|